The Pharmaceutical Quality Assurance/Quality Control Specialist will support the implementation of the USP PQM work plan activities in Indonesia related to strengthening BPOM central and provincial laboratories, supporting post-marketing surveillance activities, providing training support and project reporting. Activities are focused on quality control of medicines and diagnostics products for tuberculosis and HIV control programs in Indonesia. The Technical Advisor is expected to provide high-level technical assistance to the Government of Indonesia and to local manufacturers (as needed) on basic and compendial testing based on ISO/IEC 17025, GLP requirements for WHO Prequalification of Quality Control laboratories, ICH (The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), USP, and other relevant standards. This project is funded under the USAID Indonesia mission Office of Health in Jakarta, Indonesia.

MAIN RESPONSIBILITIES:

Provide ongoing training and technical assistance support to BPOM and other quality control laboratories in Indonesia on basic and compendial testing under the USP PQM program.

Provide assistance to BPOM staff at National and Provincial Lab on drafting and review and implementation of their SOP or written procedures.

Provide assistance and support BPOM staff at National and Provincial Lab on implementation of Quality Management System

Coordinate activities under GFATM support, including liaising with national TB and AIDS programs, BINFAR, and BPOM

Support CoP and USP PQM QA/QC senior management and staff to implement TB and HIV work plans including conducting sampling and testing of medicines throughout supply chain.

Travel to central or provincial BPOM and BBPOM QC labs as needed for training, follow-up, and project implementation.